Published April 06, 2011
Acid-suppressing drugs like Prilosec and Prevacid may not be much help for infants with troublesome acid reflux, and there's too little evidence that they help older children and teenagers, a new research review concludes.
The findings, reported in the journal Pediatrics, question the usefulness of so-called proton-pump inhibitors in children with gastroesophageal reflux disease, or GERD.
The drugs, which suppress stomach-acid production, have names like omeprazole (Prilosec), lansoprazole (Prevacid) and esomeprazole (Nexium). Prilosec and Prevacid are both available over the counter, and typically cost about 50 cents per pill. Nexium is still only available by prescription, and is more expensive.
In the new study, the researchers reviewed 12 clinical trials that tested the medications for treating GERD in infants, children or teenagers.
They found no good evidence that the drugs eased acid-reflux symptoms in infants -- such as crying and "fussing" after being fed.
For older kids, there was better evidence of a benefit. But there is still too little data on the long-term effectiveness and safety of proton-pump inhibitors for children's GERD, the researchers say.
However, that does not mean a child should never take a proton-pump inhibitor, according to lead researcher Dr. Rachel J. van der Pol, of Emma Children's Hospital in Amsterdam.
In individual infants and children, prescribing one of these medications can be justified, she told Reuters Health in an email.
But parents should also be aware, van der Pol said, that the medications simply may not work.
Healthy infants and children commonly have some acid reflux, where stomach contents back up into the esophagus. Nearly all infants "spit up," and usually that gradually goes away during the first year of life.
GERD may be diagnosed, though, when the acid reflux causes bothersome symptoms, like a sore throat or trouble swallowing, of if a child develops complications. Those include inflammation in the lining of the esophagus, or eating difficulties that affect a child's growth.
One recent study found that in North America, GERD was diagnosed in 12 percent of infants and 1 percent of older children.
Proton-pump inhibitors are one of the common treatments for childhood GERD, according to Dr. Steven J. Czinn at the University of Maryland School of Medicine in Baltimore.
Czinn, who chairs the American College of Gastroenterology's Pediatric Gastrointestinal Committee and was not involved in the study, told Reuters
Health the new findings don't mean parents should necessarily object to trying the medications.
One reason, Czinn said, is that there is evidence that proton-pump inhibitors can help treat children with an inflamed esophagus lining due to acid reflux.
In addition, he said, "I would caution against drawing conclusions from a review of 12 studies."
He noted that the researchers found hundreds of studies on pediatric GERD treatment, but only a dozen fit their criteria -- that is, being a trial where children were randomly assigned to take a proton-pump inhibitor or a comparison treatment.
According to Czinn, that highlights a big obstacle in pediatrics in general: In the case of most medications, there are few rigorously conducted trials involving children.
"This is a major issue for almost all medications in pediatrics," said Czinn.
In the realm of medical evidence, the "gold standard" is the randomized, placebo-controlled trials -- where people are randomly assigned to take the drug under study or an inactive substance, like sugar pills.
But many question the ethics of doing such trials with children; and few parents seem willing to take the chance that their child will be assigned to a placebo instead of actual treatment.
Even among the 12 studies in the current review, few involved a placebo. All of the studies of older children either tested a proton-pump inhibitor against another heartburn medication -- such as ranitidine (Zantac) -- or tested different doses of a proton-pump inhibitor against each other.
On average, children and teenagers did have improvements in their GERD symptoms. But they had similar improvements with proton-pump inhibitors and the comparison medications, and there were no clear differences with higher or lower doses.
Both van der Pol and Czinn said that further, well-designed trials are needed to see how effective and safe proton-pump inhibitors are for children.
In the studies in this review, the drugs were generally "well-tolerated" in the short-term (generally over a few weeks to a couple months), according to the researchers. The most common side effects included headache, stomach pain and diarrhea.
One study of infants, though, found that babies treated with proton-pump inhibitors had a higher rate of lung infections.
Many babies and children with acid reflux can forgo medication altogether, both van der Pol and Czinn pointed out.
For infants, thickeners added to formula, or changes in feeding position, can work. For older children, changes like eating smaller meals or avoiding specific foods that trigger symptoms can be enough.
If those steps are not enough, there are medication options other than proton-pump inhibitors. Doctors often prescribe acid-suppressing medications called H2 blockers -- which, along with Zantac, include famotidine (Pepcid) and cimetidine (Tagamet).
However, van der Pol pointed out, there isn't much evidence on the effectiveness of any medication for pediatric GERD.
Two of van der Pol's co-researchers on the study have financial ties to AstraZeneca, which makes Prilosec and Nexium.